Safety evaluation of medical devices:
Gespeichert in:
| 1. Verfasser: | |
|---|---|
| Format: | Buch |
| Sprache: | English |
| Veröffentlicht: |
New York [u.a.]
Dekker
2002
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| Ausgabe: | 2. ed., rev. and expanded |
| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis |
| Beschreibung: | XII, 558 S. Ill. |
| ISBN: | 082470617X |
Internformat
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| 245 | 1 | 0 | |a Safety evaluation of medical devices |c Shayne Cox Gad |
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| 300 | |a XII, 558 S. |b Ill. | ||
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| 650 | 4 | |a Biocompatibility |x Testing | |
| 650 | 4 | |a Biocompatible Materials | |
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| 650 | 4 | |a Biomedical materials |x Toxicity testing | |
| 650 | 4 | |a Equipment Failure | |
| 650 | 4 | |a Equipment Safety | |
| 650 | 4 | |a Materials Testing | |
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Datensatz im Suchindex
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|---|---|
| adam_text | AFETY EVALUATION OF MEDICAL DEVICES SECOND EDITION REVISED AND EXPANDED
SHAYNE COX GAD GAD CONSULTING SERVICES CARY, NORTH CAROLINA M A R C E L
MARCEL DEKKER, INC. NEW YORK * BASEL CONTENTS PREFACE TO THE SECOND
EDITION V PREFACE TO THE FIRST EDITION VII 1 INTRODUCTION 1 I.
BIOCOMPATIBILITY 2 II. SCOPE OF DEVICES AND THE MEDICAL DEVICE MARKET 5
III. HISTORY 6 IV. NONSPECIFIC REGULATORY CONSIDERATIONS 8 REFERENCES 11
2 REGULATORY ASPECTS AND STRATEGY IN MEDICAL DEVICE AND BIOMATERIALS
SAFETY EVALUATION 13 I. REGULATORY BASIS 13 II. TOXICITY TESTING:
MEDICAL DEVICES 21 REFERENCES 51 3 ROAD MAP TO TEST SELECTIONS 53 I. KEY
CONCEPTS 53 II. CONDITIONS OF USE 53 III. MATERIALS, COMPONENTS, AND
PRODUCTS 54 IV. PRIOR KNOWLEDGE 83 V. TYPES AND USES OF TESTS 95
REFERENCES 100 IX X CONTENTS 4 WHAT TO TEST: SAMPLING AND SAMPLE
PREPARATION 105 105 107 108 115 116 116 I. II. III. IV. V. SAMPLING
RANDOMIZATION SAMPLE PREPARATION REFERENCE MATERIALS CONCLUSION
REFERENCES 5 CYTOTOXICITY TESTING I. BACKGROUND II. III. CYTOTOXICITY
ASSAYS CONCLUSION REFERENCES 117 118 122 128 129 6 BLOOD COMPATIBILITY
131 I. INTRODUCTION 131 II. STANDARD TESTS 138 III. CONCLUSION 147
REFERENCES 147 7 IRRITATION AND PYROGENICITY 149 I. DERMAL IRRITATION
150 IL OCULAR IRRITATION TESTING 158 III. OTHER NONPARENTERAL ROUTE
IRRITATION TESTS 165 IV. PARENTERAL IRRITATION/TOLERANCE 166 V.
PARENTERAL ROUTES 167 VI. INTRACUTANEOUS IRRITATION 173 VII. PROBLEMS IN
TESTING (AND THEIR RESOLUTIONS) 184 REFERENCES 184 8 IMMUNOTOXICOLOGY
191 I. OVERVIEW OF THE IMMUNE SYSTEM 193 II. EVALUATION OF THE IMMUNE
SYSTEM 211 III. LOCAL LYMPH NODE ASSAY 251 IV. APPROACHES 255 V.
PROBLEMS AND FUTURE DIRECTIONS 259 REFERENCES 261 9 IMPLANTATION BIOLOGY
AND STUDIES 269 I. USP IMPLANTATION TEST 269 II. BRITISH PHARMACOPOEIA
271 III. ISO 10993 IMPLANTATION TEST 272 XI IV. TEST METHOD FOR
IMPLANTATION IN SUBCUTANEOUS TISSUE 278 V. TEST METHOD FOR IMPLANTATION
IN MUSCLE 279 VI. TEST METHOD FOR IMPLANTATION IN BONE 280 VII. CONTROL
MATERIALS 282 VIII. LONG-TERM IMPLANT STUDIES 283 IX. CONSIDERATIONS 292
REFERENCES 292 10 GENOTOXICITY 295 I. DNA STRUCTURE 297 II. CYTOGENETICS
308 III. IN VITRO CYTOGENETIC ASSAYS 340 IV. IN VIVO CYTOGENETIC ASSAYS
345 V. SISTER CHROMATID EXCHANGE ASSAYS 348 REFERENCES 350 11 SUBCHRONIC
AND CHRONIC TOXICITY AND REPRODUCTIVE AND DEVELOPMENTAL TOXICITY 363 I.
OBJECTIVES 363 II. REGULATORY CONSIDERATIONS 364 III. PARAMETERS TO
MEASURE 367 IV. HISTOPATHOLOGY 373 V. STUDY INTERPRETATION AND REPORTING
376 VI. REPRODUCTIVE AND DEVELOPMENTAL TOXICITY 376 REFERENCES 397 12
CARCINOGENICITY 403 I. ANIMAL MODEL 404 II. DOSE SELECTION 406 III.
INTERPRETATION OF RESULTS 413 REFERENCES 413 13 STERILITY,
STERILIZATION, AND HEAVY METALS 417 I. STERILITY 417 II. HEAVY METALS
426 REFERENCES 428 14 COMBINATION DEVICES 431 I. COMBINATION PRODUCTS
431 IL DEVICE PROGRAMS THAT CDER AND CBRH WILL ADMINISTER 439 REFERENCES
448 XII CONTENTS 15 CLINICAL STUDIES FOR MEDICAL DEVICES 449 I. DESIGN
CONSIDERATIONS 450 II. EPIDEMIOLOGY 464 III. CONCLUSION 474 REFERENCES
474 16 SPECIAL STUDIES 477 I. CARDIOVASCULAR DEVICES AND PROSTHESES 477
II. TAMPONS 482 III. CONTACT LENSES AND THEIR SOLUTIONS 483 IV. SPECIFIC
TESTS 483 V. TWENTY-ONE-DAY EYE IRRITATION STUDY IN RABBITS 494 VI.
SYSTEMIC INJECTION TEST 495 VII. PRODUCTION OF TOXIC SHOCK SYNDROME
TOXIN-1 (TSST-1) 497 VIII. IN VITRO EVALUATION OF THE EFFECTS OF
POTENTIAL TAMPON MATERIALS ON PH AND GROWTH OF VAGINAL MICROFLORA 499
IX. INFLAMMATORY RESPONSES TO BIOMATERIALS 501 REFERENCES 501 17 CASE
HISTORIES AND PROBLEM RESOLUTION 505 I. PHTHALATE AND OTHER RESIDUAIS
LEACHING FROM DEVICES 505 II. DALKON SHIELD 506 III. TALE ON GLOVES AND
CONDOMS 509 IV. TOXIC SHOCK SYNDROME 511 V. LATEX ALLERGY 514 VI.
SILICONES IN DEVICES 516 VII. PROBLEM SOLVING 522 VIII. RISK ASSESSMENTS
525 IX. CONCLUSION 531 REFERENCES 531 APPENDIX A: SELECTED REGULATORY
AND TOXICOLOGICAL ACRONYMS AND ABBREVIATIONS 537 APPENDIX B: CONTRACT
TESTING LABORATORIES 541 APPENDIX C: NOTABLE REGULATORY INTERNET
ADDRESSES 543 APPENDIX D: NON-U.S. MEDICAL DEVICE REGULATORS 549 INDEX
551
|
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| building | Verbundindex |
| bvnumber | BV014150390 |
| callnumber-first | R - Medicine |
| callnumber-label | R857 |
| callnumber-raw | R857.M3 |
| callnumber-search | R857.M3 |
| callnumber-sort | R 3857 M3 |
| callnumber-subject | R - General Medicine |
| classification_rvk | YI 3200 |
| ctrlnum | (OCoLC)48656143 (DE-599)BVBBV014150390 |
| dewey-full | 681/.761/0287 |
| dewey-hundreds | 600 - Technology (Applied sciences) |
| dewey-ones | 681 - Precision instruments and other devices |
| dewey-raw | 681/.761/0287 |
| dewey-search | 681/.761/0287 |
| dewey-sort | 3681 3761 3287 |
| dewey-tens | 680 - Manufacture of products for specific uses |
| discipline | Handwerk und Gewerbe / Verschiedene Technologien Medizin |
| edition | 2. ed., rev. and expanded |
| format | Book |
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| id | DE-604.BV014150390 |
| illustrated | Illustrated |
| indexdate | 2024-07-09T18:58:34Z |
| institution | BVB |
| isbn | 082470617X |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-009698036 |
| oclc_num | 48656143 |
| open_access_boolean | |
| owner | DE-355 DE-BY-UBR DE-703 |
| owner_facet | DE-355 DE-BY-UBR DE-703 |
| physical | XII, 558 S. Ill. |
| publishDate | 2002 |
| publishDateSearch | 2002 |
| publishDateSort | 2002 |
| publisher | Dekker |
| record_format | marc |
| spelling | Gad, Shayne C. Verfasser aut Safety evaluation of medical devices Shayne Cox Gad 2. ed., rev. and expanded New York [u.a.] Dekker 2002 XII, 558 S. Ill. txt rdacontent n rdamedia nc rdacarrier Biocompatibility Testing Biocompatible Materials Biomedical materials Testing Biomedical materials Toxicity testing Equipment Failure Equipment Safety Materials Testing Toxicity Tests Biomaterial (DE-588)4267769-5 gnd rswk-swf Sicherheitstestung (DE-588)4140868-8 gnd rswk-swf Biomaterial (DE-588)4267769-5 s Sicherheitstestung (DE-588)4140868-8 s DE-604 GBV Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=009698036&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Gad, Shayne C. Safety evaluation of medical devices Biocompatibility Testing Biocompatible Materials Biomedical materials Testing Biomedical materials Toxicity testing Equipment Failure Equipment Safety Materials Testing Toxicity Tests Biomaterial (DE-588)4267769-5 gnd Sicherheitstestung (DE-588)4140868-8 gnd |
| subject_GND | (DE-588)4267769-5 (DE-588)4140868-8 |
| title | Safety evaluation of medical devices |
| title_auth | Safety evaluation of medical devices |
| title_exact_search | Safety evaluation of medical devices |
| title_full | Safety evaluation of medical devices Shayne Cox Gad |
| title_fullStr | Safety evaluation of medical devices Shayne Cox Gad |
| title_full_unstemmed | Safety evaluation of medical devices Shayne Cox Gad |
| title_short | Safety evaluation of medical devices |
| title_sort | safety evaluation of medical devices |
| topic | Biocompatibility Testing Biocompatible Materials Biomedical materials Testing Biomedical materials Toxicity testing Equipment Failure Equipment Safety Materials Testing Toxicity Tests Biomaterial (DE-588)4267769-5 gnd Sicherheitstestung (DE-588)4140868-8 gnd |
| topic_facet | Biocompatibility Testing Biocompatible Materials Biomedical materials Testing Biomedical materials Toxicity testing Equipment Failure Equipment Safety Materials Testing Toxicity Tests Biomaterial Sicherheitstestung |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=009698036&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
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